Pontic Site Development With or Without Fixed Partial Denture (Pontic Site)

April 27, 2026 updated by: Ahmed Mohamed Hassan Elatreby, Cairo University

Clinical and Volumetric Evaluation of Soft Tissue Augmentation Using Connective Tissue Graft (CTG) in Pontic Site Defects With and Without Fixed Partial Dentures. A Non-randomized Clinical Trial.

This study aims to evaluate the effectiveness of soft tissue augmentation using connective tissue graft (CTG) in pontic site defects. It compares clinical and volumetric outcomes between sites with an existing fixed partial denture (FDP) and sites without an FDP.

Following tooth extraction, alveolar ridge resorption often leads to soft tissue defects that can compromise esthetics, function, and prosthetic outcomes. CTG is considered the gold standard for soft tissue augmentation due to its predictable improvement in tissue thickness and stability.

In this non-randomized clinical trial, patients with single edentulous sites in the esthetic zone will undergo CTG using a standardized surgical technique. The primary outcome is keratinized tissue thickness, while secondary outcomes include keratinized tissue width, volumetric soft tissue changes, esthetic evaluation (Pink Esthetic Score), plaque index, post-operative pain, and patient satisfaction.

Clinical and digital assessments will be conducted preoperatively and at follow-up intervals up to 6 months. The study aims to determine whether performing CTG around an existing bridge provides comparable or improved outcomes compared to sites without a bridge, potentially offering a less invasive alternative to prosthetic replacement.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Alveolar ridge resorption following tooth extraction frequently results in soft tissue deficiencies that compromise esthetic outcomes, prosthetic design, phonetics, and oral hygiene. In pontic site defects, inadequate soft tissue volume may lead to poor emergence profile, food impaction, and patient dissatisfaction, especially in the esthetic zone.

Soft tissue augmentation using connective tissue graft (CTG) is widely recognized as a reliable technique for improving tissue thickness and contour. However, limited evidence exists regarding its effectiveness when performed around an existing fixed partial denture (FDP), where removal of the prosthesis is often considered necessary before augmentation.

This study aims to evaluate whether soft tissue augmentation can be successfully performed without removing an existing prosthesis, and whether outcomes are comparable to sites where no prosthesis is present.

A non-randomized, parallel clinical design will be used to compare two clinical scenarios: pontic sites associated with an existing FDP and pontic sites without an FDP. The same surgical approach will be applied in both conditions to ensure consistency, with the presence or absence of the prosthesis being the primary distinguishing factor.

All procedures will be carried out under standardized clinical conditions at the Faculty of Dentistry, Cairo University. Patients will undergo initial periodontal preparation prior to surgical intervention. The augmentation procedure will be performed using a connective tissue graft placed through a minimally invasive pouch technique to enhance soft tissue volume and contour.

Follow-up assessments will be conducted over a 6-month period to evaluate healing, tissue stability, and overall clinical performance.

The significance of this study lies in its potential to support a less invasive treatment approach by eliminating the need for prosthesis removal, which may reduce treatment time, cost, and patient discomfort while maintaining satisfactory clinical and esthetic outcomes.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 12613
        • Recruiting
        • Faculty of Dentistry, Cairo University
        • Contact:
        • Principal Investigator:
          • Ahmed Mohamed Elatreby, BDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients will on missing tooth in the esthetic zone (2nd premolar to 2nd premolar), missing at least 3 months prior to recruitment, with or without FPD
  • Systemically free patient
  • ≥18 years of age
  • Intact gingival tissue with at least 2mm keratinized tissue in adjacent teeth
  • Patients accept to provide informed consent

Exclusion Criteria:

  • Smokers.
  • Pregnancy and lactation
  • Periodontitis
  • Severe gagging reflex
  • Handicapped and mentally challenged patients
  • Active soft tissue infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CTG with Existing Fixed Partial Denture
Participants with pontic site defects associated with an existing fixed partial denture (FDP) will receive soft tissue augmentation using a connective tissue graft (CTG) without removal of the prosthesis.
Procedure: Connective Tissue Graft (CTG)
Soft tissue augmentation will be performed using a subepithelial connective tissue graft (CTG) harvested from the palate and placed at the pontic site using a minimally invasive pouch/tunnel technique. The procedure aims to increase soft tissue thickness and improve contour in edentulous ridge defects. The same surgical protocol will be applied in all participants, with variation based only on the presence or absence of an existing fixed partial denture.
Other Names:
  • Subepithelial Connective Tissue Graft
  • Soft Tissue Augmentation
Experimental: CTG without Fixed Partial Denture
Participants with pontic site defects without an existing fixed partial denture will receive soft tissue augmentation using a connective tissue graft (CTG). A temporary bridge will be provided during healing.
Procedure: Connective Tissue Graft (CTG)
Soft tissue augmentation will be performed using a subepithelial connective tissue graft (CTG) harvested from the palate and placed at the pontic site using a minimally invasive pouch/tunnel technique. The procedure aims to increase soft tissue thickness and improve contour in edentulous ridge defects. The same surgical protocol will be applied in all participants, with variation based only on the presence or absence of an existing fixed partial denture.
Other Names:
  • Subepithelial Connective Tissue Graft
  • Soft Tissue Augmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized Tissue Thickness
Time Frame: Baseline and 6 months
Measured in millimeters using transgingival probing
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized Tissue Width
Time Frame: Baseline and 6 month
Measured in millimeters using periodontal probe
Baseline and 6 month
Volumetric contour changes
Time Frame: Baseline, 3 months, and 6 months
Assessed using digital intraoral scanning and 3D analysis
Baseline, 3 months, and 6 months
Blinded assessment for esthetics
Time Frame: 6 months

Calibration of the Assessors: Before initiating clinical measurements, 3 assessors will undergo calibration to ensure reliability and reduce intra-examiner variability. The calibration will aim for a kappa (κ) value greater than 0.75 to confirm consistency.

The assessors will be trained to score according to the PES Blinding of the Assessors: The assessors will be masked and remain unaware of treatment group assignments. Assessors will not be any part of the ttt process
6 months
Post-operative pain
Time Frame: Day 3, day 7, and day 14
Measured using Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst pain)
Day 3, day 7, and day 14
Patient satisfaction
Time Frame: 6 months
Assessed using quality-of-life questionnaire
6 months
Pink Esthetic Score (PES)
Time Frame: 6 months
It consists of seven variables, each scored 0-1-2 (with 2 being best), for a maximum score of 14, assessing papillae, tissue level, contour, color, texture, and alveolar process.
6 months
Plaque Index
Time Frame: Baseline and 6 Months
Assessed using plaque index ranging from 0 (no plaque) to 3 (abundant plaque)
Baseline and 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Enji Ahmed Mahmoud, PHD holder, Professor of Oral Medicine and Periodontology - Faculty of Dentistry, Cairo University.
  • Study Director: Omnia Khaled Tawfik, PHD Holder, Lecturer of Oral Medicine and Periodontology- Cairo University.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PER 3-3-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Connective Tissue Graft

Clinical Trials on Connective Tissue Graft (CTG)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe